Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)

The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
• Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
• On a stable medication regimen for IOP reduction one week prior to the screening visit;
• Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
• Sign informed consent;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
• Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
• Infection in either eye;
• Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
• Risk for visual field or visual acuity worsening, in the opinion of the investigator;
• Women of childbearing potential;
• Pregnant or lactating women;
• Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
• Participation in another clinical study within 30 days before the screening visit;
• Other protocol-defined exclusion criteria may apply.